Trial Outcomes & Findings for Medacta NextAR TKA Pivotal Trial (NCT NCT04844879)

NCT ID: NCT04844879

Last Updated: 2025-10-14

Results Overview

Oxford Knee Score (OKS) \[Range: 0-48; higher values indicate better outcomes\]

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-10-14

Participant Flow

Unit of analysis: Knees

Participant milestones

Measure	NextAR TKA Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data (Each unit represents a single patient)
Overall Study STARTED	40 40
Overall Study 2-month Follow up	40 40
Overall Study 6-month Follow up	39 39
Overall Study 12-month Follow up	37 37
Overall Study COMPLETED	37 37
Overall Study NOT COMPLETED	3 3

Reasons for withdrawal

Measure	NextAR TKA Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data (Each unit represents a single patient)
Overall Study Death	1
Overall Study Withdrawal by Subject	1
Overall Study Adverse Event	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	NextAR TKA n=40 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Age, Continuous	70.0 years n=40 Participants
Sex: Female, Male Female	28 Participants n=40 Participants
Sex: Female, Male Male	12 Participants n=40 Participants
Oxford Knee Score	26.5 score on a scale n=40 Participants
Forgotten Joint Score	15.6 score on a scale n=40 Participants
Objective Knee Society Score	45.5 score on a scale n=40 Participants

PRIMARY outcome

Timeframe: 6 months

Oxford Knee Score (OKS) [Range: 0-48; higher values indicate better outcomes]

Outcome measures

Measure	NextAR TKA n=39 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Oxford Knee Score (OKS)	39 scores on a scale Interval 33.0 to 43.0

SECONDARY outcome

Timeframe: 12 months

Oxford Knee Score (OKS) [Range: 0-48; higher values indicate better outcomes]

Outcome measures

Measure	NextAR TKA n=37 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Oxford Knee Score (OKS)	41 score on a scale Interval 36.0 to 46.0

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Lost at 6-month follow up: 1 Lost at 12-month follow up: 2

Forgotten Joint Score (FJS) [Range: 0-100; higher values indicate better outcomes]

Outcome measures

Measure	NextAR TKA n=39 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Forgotten Joint Score (FJS) 6-month follow up	56.2 score on a scale Interval 30.2 to 78.1
Forgotten Joint Score (FJS) 12-month follow up	60.4 score on a scale Interval 45.8 to 91.7

SECONDARY outcome

Timeframe: 6 months and 12 months

Population: Objective KSS. Lost at 6-month follow up: 1. Lost at 12-month follow up: 2.

Objective Knee Society Score (KSS) [Range: 0-100; higher values indicate better outcomes; total score reported as the average of subscale scores]

Outcome measures

Measure	NextAR TKA n=39 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Objective Knee Society Score (KSS) 6-month follow up	87.0 score on a scale Interval 63.0 to 96.0
Objective Knee Society Score (KSS) 12-month follow up	88.5 score on a scale Interval 44.0 to 99.0

SECONDARY outcome

Timeframe: 2 months and 12 months

Population: Lost at 12-month follow up: 3

X-ray assessment for the evaluation of: implant positioning, presence of radiolucent lines, subsidence, migration of components, presence of heterotopic ossifications or osteolysis

Outcome measures

Measure	NextAR TKA n=40 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Radiological Outcomes 2-month follow up · No Radiolucency (>2mm), Subsidence, Loosening	40 Participants
Radiological Outcomes 2-month follow up · Radiolucency (>2mm) - One Gruen Zone	0 Participants
Radiological Outcomes 2-month follow up · Subsidence	0 Participants
Radiological Outcomes 2-month follow up · Loosening	0 Participants
Radiological Outcomes 12-month follow up · No Radiolucency (>2mm), Subsidence, Loosening	34 Participants
Radiological Outcomes 12-month follow up · Radiolucency (>2mm) - One Gruen Zone	3 Participants
Radiological Outcomes 12-month follow up · Subsidence	0 Participants
Radiological Outcomes 12-month follow up · Loosening	0 Participants

SECONDARY outcome

Timeframe: Intraoperative

Surgical time (min)

Outcome measures

Measure	NextAR TKA n=40 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Surgical Outcome - Surgical Time 60-80 minutes	3 Participants
Surgical Outcome - Surgical Time 81-100 minutes	18 Participants
Surgical Outcome - Surgical Time 101-120 minutes	13 Participants
Surgical Outcome - Surgical Time 121-150 minutes	6 Participants

SECONDARY outcome

Timeframe: Intraoperative

Necessity of soft tissue release to obtain ligament or patellar balance (Y/N)

Outcome measures

Measure	NextAR TKA n=40 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Surgical Outcome - Necessity of Soft Tissue Release	0 Participants

SECONDARY outcome

Timeframe: 2 months

Time to discharge (days)

Outcome measures

Measure	NextAR TKA n=40 Participants Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Surgical Outcome -Time to Discharge	4.8 days Interval 3.0 to 16.0

SECONDARY outcome

Timeframe: Intraoperative, 2 months, 6 months and 12 months

Device deficiencies and adverse events

Outcome measures

Outcome data not reported

Adverse Events

NextAR TKA

Serious events: 12 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	NextAR TKA n=40 participants at risk Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Blood and lymphatic system disorders Venous thrombosis	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Hemarthrosis	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Arthritis flare	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Accidental fall leading to TKA revision	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Eye disorders Thrombosis main vein of the eye	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Accidental fall leading to wound opening and spine surgery	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
General disorders Death	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Transient deficit in range of motion	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Carpal tunnel syndrome	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Chronic dislocation of the patella	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Ear and labyrinth disorders Benign paroxysmal positional vertigo	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%
Musculoskeletal and connective tissue disorders Arthrosis contralateral knee	2.5% 1/40 • Number of events 1 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%

Other adverse events

Measure	NextAR TKA n=40 participants at risk Patients undergoing primary TKA with use of the navigation system providing personalized soft tissue balance data
Musculoskeletal and connective tissue disorders Postoperative knee pain, inflammation, or swelling	12.5% 5/40 • Number of events 5 • From signature of the informed consent up to 12 months postoperatively. All Serious adverse events are reported. Adverse events with at least "Unknown/Possible" relation with the procedure and/or the device are reported if rate exceeds 2.5%

Additional Information

Medical Affairs Department

Medacta International SA

Phone: +41 91 696 60 60

Email: myclinicaldata@medacta.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place